Legal and Ethical issues documentation
The protection of the patients' privacy is of crucial importance for the success of scientific genetic research projects, as only if this protection can be guaranteed patients will take part in the project. Therefore ACGT makes every endeavor to guarantee the privacy of the participating patients. Being in line with all relevant legal and ethical guidelines is seen as one of the major assets of ACGT.
The new and innovative data protection framework developed in ACGT which guarantees this privacy can also be adapted to other projects and is therefore a major result of ACGT. You will find a detailed description of the ACGT Data Protection Framework in the following documents:
European Regulation
A European Community Law
- CHARTER OF FUNDAMENTAL RIGHTS OF THE EUROPEAN UNION
www.europarl.europa.eu/charter/default_en.htm - DIRECTIVE 95/46/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 24 OCTOBER 1995 - Data Protection Directive
eur-lex.europa.eu/LexUriServ/LexUriServ.do - DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices
eur-lex.europa.eu/smartapi/cgi/sga_doc - Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce')
eur-lex.europa.eu/LexUriServ/LexUriServ.do - DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 - implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
download document
UNESCO Declarations
- Universal Declaration on the Human Genome and Human Rights (1997)
portal.unesco.org/shs/en/ev.php-URL_ID=1881&URL_DO=DO_TOPIC&URL_SECTION=201.html - International Declaration on Human Genetic Data (2003)
portal.unesco.org/shs/en/ev.php-URL_ID=1882&URL_DO=DO_TOPIC&URL_SECTION=201.html - Universal Declaration on Bioethics and Human Rights (2005)
portal.unesco.org/shs/en/ev.php-URL_ID=1883&URL_DO=DO_TOPIC&URL_SECTION=201.html
Conventions of the Council of Europe
- CONVENTION OF THE COUNCIL NO. 05 FOR THE PROTECTION OF HUMAN RIGHTS AND FUNDAMENTAL FREEDOMS
conventions.coe.int/Treaty/en/Treaties/Html/005.htm - CONVENTION No. 164 OF THE COUNCIL OF EUROPE FOR THE PROTECTION OF HUMAN RIGHTS AND DIGNITY OF THE HUMAN BEING WITH REGARD TO THE APPLICATION OF BIOLOGY AND MEDICINE (Convention on Human Rights and Biomedicine)
conventions.coe.int/Treaty/EN/Treaties/html/164.htm
Other Material
- WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
www.wma.net/e/policy/b3.htm - ARTICLE 29 DATA PROTECTION WORKING PARTY: Opinion 6/2000 on the Human Genome and Privacy
ec.europa.eu/justice_home/fsj/privacy/docs/wpdocs/2000/wp34en.pdf - ARTICLE 29 DATA PROTECTION WORKING PARTY: WORKING DOCUMENT ON GENETIC DATA. Adopted on March 17, 2004.
ec.europa.eu/justice_home/fsj/privacy/docs/wpdocs/2004/wp91_en.pdf - ARTICLE 29 DATA PROTECTION WORKING PARTY: OPINION 4/2007 ON THE CONCEPT OF PERSONAL DATA. Adopted on June 20th, 2007.
ec.europa.eu/justice_home/fsj/privacy/workinggroup/wpdocs/2007_en.htm
National Law
- Austria: Datenschutzgesetz 2000
www.dsk.gv.at/dsg2000d.htm
English version:
www.dsk.gv.at/indexe.htm - Germany: Bundesdatenschutzgesetz
bundesrecht.juris.de/bdsg_1990/
- United Kingdom: Data Protection Act 1998:
www.opsi.gov.uk/ACTS/acts1998/19980029.htm
For more information you may contact Prof. Nikolaus Forgo